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NCT03593759 · ClinicalTrials.gov registry record · Phase 3
Cardiac Sarcoidosis Randomized Trial
A Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis, sponsored by Ottawa Heart Institute Research Corporation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT03593759: Recruiting Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis, sponsored by Ottawa Heart Institute Research Corporation.
NCT03593759 is a Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis that is actively recruiting participants, run by Ottawa Heart Institute Research Corporation. The registered enrollment target is 194 participants, below the 2,160-participant average among 21 other Sarcoidosis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03593759, a Phase 3 study of Sarcoidosis and Cardiac Sarcoidosis, is actively recruiting participants, sponsored by Ottawa Heart Institute Research Corporation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
Primary Outcome
Measure of myocardial scarring and fibrosis (blinded core lab analysis)
Conditions Studied
Interventions
- DRUG Methotrexate
- DRUG Prednisone or Prednisolone
Study Locations (20)
Quebec
- Montreal Heart Institute - Montreal
- CIUSSS-Hopital du Sacre-Coeur de Montreal - Montreal
- Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval - Québec
- CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont - Sherbrooke
Ontario
- St. Joseph's Healthcare Centre - Hamilton
- London Health Sciences Centre - London
- University of Ottawa Heart Institute - Ottawa
Connecticut
- Yale-New Haven Hospital - New Haven
Massachusetts
- Tufts Medical Center - Boston
Michigan
- University of Michigan-Michigan Medicine Cardiovascular Center - Ann Arbor
Minnesota
- University of Minnesota - Minneota
New York
- Montefiore Medical Center - New York
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
What NCT03593759 shows while recruiting
NCT03593759 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 2,160-participant average among 21 other Sarcoidosis trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Sarcoidosis appearing as the primary indexed condition, and to 2 interventions - of which Methotrexate is the first listed.
NCT03593759 names 20 study sites across 15 states, led by Quebec, Ontario, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03593759 about?
NCT03593759 is a clinical study titled "Cardiac Sarcoidosis Randomized Trial". Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low do...
What is the current status of trial NCT03593759?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2019-01-15. Estimated completion is 2025-12.
What conditions does trial NCT03593759 study?
This clinical trial studies the following conditions: Sarcoidosis, Cardiac Sarcoidosis.
What interventions are being tested in trial NCT03593759?
The interventions under investigation include: Methotrexate (DRUG), Prednisone or Prednisolone (DRUG).
Who is sponsoring clinical trial NCT03593759?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03593759 being conducted?
This trial has 20 study locations across Connecticut, Massachusetts, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03593759's enrollment target sits among peer trials
194 8th of 21 higher than 14 of 21 other Sarcoidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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